Clinical Research Directory

Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women

This study aims to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders of pregnancy. Pregnant women with hypertensive disorders who meet the eligibility criteria will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive prenatal education based on the Roy Adaptation Model in two face-to-face sessions, one week apart. The control group will receive routine antenatal care. Blood pressure monitoring will be recommended for participants in both groups. Perceived stress and quality of life will be assessed before the education and after the intervention. The study will investigate whether Roy Adaptation Model-based prenatal education helps reduce perceived stress and improve quality of life among pregnant women with hypertensive disorders.

Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy

The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.

Postpartum Home Visiting (HEART at Home)

The goal of this clinical trial is to learn whether HEART at Home (Home-based Engagement And Remote Treatment for Hypertension), a home-based postpartum hypertension care program, is feasible and acceptable for people with high blood pressure after delivery and the health care teams caring for them. The main questions it aims to answer are: Is HEART at Home feasible to deliver, including successful enrollment, completion of home visits and blood pressure monitoring, and delivery of the planned intervention? Is HEART at Home acceptable to participants and health care providers? The study will also explore changes in blood pressure control and track emergency room visits and hospital readmissions related to high blood pressure. Participants will: Measure their blood pressure at home using a provided blood pressure cuff and securely share their readings with the health care team. Receive home visits and phone or text check-ins from trained postpartum doulas for the first three months after delivery. Doulas will provide education, assist with blood pressure monitoring, and help participants connect with ongoing medical care. Have their blood pressure readings reviewed by nurses and doctors, who may adjust blood pressure medications as needed. At 12 weeks after delivery, a plan set for ongoing care with a primary care provider or heart specialist.

Cost-Effectiveness of an mHealth Application in Pregnancy Care

Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the recommendation of their study physician.

Self-Management App for Blood Pressure and Well-Being in Postpartum Women With Hypertensive Disorders of Pregnancy

Hypertensive disorders of pregnancy (HDP) are a major cause of maternal morbidity and may continue to affect women after childbirth. Effective postpartum self-management is important for controlling blood pressure (BP) and improving overall health. eHealth applications may provide convenient tools to support self-monitoring and promote healthy behaviors. The purpose of this randomized controlled trial is to evaluate the effectiveness of a self-management application for postpartum women with hypertensive disorders of pregnancy (HDP). Participants are randomly assigned to either a self-management app intervention group or a usual care group. The study assesses whether the application improves blood pressure (BP)control, psychological well-being (stress and depression), and health-promoting lifestyle behaviors among postpartum women.

Mobile Health Program for Post-Preeclampsia Hypertension

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

Clinician Notification to Increase Aspirin Prophylaxis for Preeclampsia Prevention

Preeclampsia is a leading cause of maternal morbidity and mortality. Low-dose aspirin prophylaxis reduces preeclampsia risk among high-risk pregnant individuals but remains underused in routine clinical practice. This pragmatic cluster-randomized implementation trial will test whether clinician notification of elevated preeclampsia risk increases aspirin prophylaxis utilization among eligible pregnant individuals receiving outpatient obstetric care. Clusters will be randomized to clinician notification versus usual care. In the intervention arm, obstetric clinicians will receive notification that a patient is at elevated risk for preeclampsia and a recommendation to consider initiation of aspirin prophylaxis between 12 and 28 weeks' gestation, as clinically appropriate. The intervention does not assign participants to aspirin and does not require any study-mandated medication. All decisions regarding aspirin prophylaxis will remain at the discretion of the treating obstetric clinician and patient.